Olmesartan and hydrochlorothiazide (Oral route)

Pronunciation:

Brand Names:

Dosage Forms:

Warnings:

Drugs that act directly on the renin-angiotensin system can cause injury or death to the developing fetus when used during pregnancy. Stop therapy as soon as possible if pregnancy is detected .

Classifications:

Therapeutic—

Angiotensin II Receptor Antagonist/Thiazide Combination

Pharmacologic—

Angiotensin II Receptor Antagonist

Chemical—

Thiazide

Uses of This Medicine:

Olmesartan and hydrochlorothiazide combination is used alone or together with other medicines to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. Lowering blood pressure can reduce the risk of strokes and heart attacks.

Olmesartan is an angiotensin II receptor blocker (ARB). It works by blocking a substance in the body that causes blood vessels to tighten. As a result, olmesartan relaxes the blood vessels. This lowers blood pressure and increases the supply of blood and oxygen to the heart.

Hydrochlorothiazide is a thiazide diuretic (water pill). It reduces the amount of water in the body by increasing the flow of urine, which helps lower the blood pressure.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of olmesartan and hydrochlorothiazide combination in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of olmesartan and hydrochlorothiazide combination in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving olmesartan and hydrochlorothiazide combination.

Pregnancy—

Pregnancy Category

Explanation

1st Trimester

C

Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

2nd Trimester

D

Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

3rd Trimester

D

Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Dofetilide

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acetyldigoxin

Arsenic Trioxide

Benazepril

Captopril

Cyclophosphamide

Deslanoside

Digitalis

Digitoxin

Digoxin

Droperidol

Enalapril

Enalaprilat

Flecainide

Fosinopril

Ketanserin

Levomethadyl

Lisinopril

Lithium

Methotrexate

Metildigoxin

Moexipril

Ouabain

Perindopril Erbumine

Proscillaridin

Quinapril

Ramipril

Sotalol

Trandolapril

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Aceclofenac

Acemetacin

Alacepril

Amtolmetin Guacil

Aspirin

Benazepril

Bepridil

Bromfenac

Bufexamac

Captopril

Carbamazepine

Celecoxib

Chlorpropamide

Cholestyramine

Choline Salicylate

Cilazapril

Clonixin

Colesevelam

Delapril

Dexibuprofen

Dexketoprofen

Diclofenac

Diflunisal

Dipyrone

Enalaprilat

Enalapril Maleate

Etodolac

Etofenamate

Etoricoxib

Felbinac

Fenoprofen

Fepradinol

Feprazone

Floctafenine

Flufenamic Acid

Flurbiprofen

Fosinopril

Ginkgo

Glipizide

Gossypol

Ibuprofen

Ibuprofen Lysine

Imidapril

Indomethacin

Ketoprofen

Ketorolac

Licorice

Lisinopril

Lornoxicam

Loxoprofen

Lumiracoxib

Meclofenamate

Mefenamic Acid

Meloxicam

Moexipril

Morniflumate

Nabumetone

Naproxen

Nepafenac

Niflumic Acid

Nimesulide

Oxaprozin

Oxyphenbutazone

Parecoxib

Pentopril

Perindopril

Phenylbutazone

Piketoprofen

Piroxicam

Pranoprofen

Proglumetacin

Propyphenazone

Proquazone

Quinapril

Ramipril

Rofecoxib

Salicylic Acid

Salsalate

Sodium Salicylate

Spirapril

Sulindac

Temocapril

Tenoxicam

Tiaprofenic Acid

Tolfenamic Acid

Tolmetin

Topiramate

Trandolapril

Valdecoxib

Zofenopril

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Anuria (not able to form urine) or

Diabetic patients who are also taking aliskiren (Tekturna®) or

Patients with kidney problems who are also taking aliskiren (Tekturna®) or

Sulfa drug allergy, history of—Should not be used in patients with these conditions.

Asthma, or history of or

Dehydration, severe or

Hyponatremia (low sodium in the blood)—Use with caution. May cause side effects to become worse.

Congestive heart failure, severe—Use may lead to kidney problems.

Diabetes or

Glaucoma, secondary angle closure or

Gout or

Hypercalcemia (high calcium in the blood) or

Hyperlipidemia (high cholesterol or fats in the blood) or

Hyperuricemia (high uric acid in the blood) or

Hypokalemia (low potassium in the blood) or

Hypomagnesemia (low magnesium in the blood) or

Liver disease or

Myopia (nearsighted; can't see objects at a distance) or

Systemic lupus erythematosus (immune system disease)—Use with caution. May make these conditions worse.

Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

In addition to using this medicine, treatment for your high blood pressure may include weight control and changes in the types of foods you eat, especially foods high in sodium (salt). Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet.

Many patients who have high blood pressure will not notice any signs of the problem. In fact, many may feel normal. It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well.

Remember that this medicine will not cure your high blood pressure but it does help control it. Therefore, you must continue to take it as directed if you expect to lower your blood pressure and keep it down. You may have to take high blood pressure medicine for the rest of your life. If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke, or kidney disease.

You may take this medicine with or without food.

If you are also using colesevelam (Welchol®), take it at least 4 hours after taking Benicar HCT®.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (tablets):

For high blood pressure:

Adults—One tablet once a day. Your doctor may increase your dose if needed.

Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using this medicine, tell your doctor right away.

Dizziness, lightheadedness, or fainting may also occur, especially when you get up from a lying or sitting position or if you have been taking a diuretic (water pill). Make sure you know how you react to the medicine before you drive, use machines, or do other things that could be dangerous if you are dizzy or not alert. If you feel dizzy, lie down so you do not faint. Then sit for a few moments before standing to prevent the dizziness from returning.

Check with your doctor right away if you become sick while taking this medicine, especially with severe or continuing nausea, vomiting, or diarrhea that does not stop. These conditions may cause you to lose too much water or salt and lead to low blood pressure. You can also lose water by sweating, so drink plenty of water during exercise or in hot weather.

Severe, chronic diarrhea with weight loss may develop months to years after taking this medicine. Tell your doctor right away if you have these symptoms.

Check with your doctor right away if blurred vision, difficulty with reading, eye pain, or any other change in vision occurs during or after treatment. This could be a sign of a serious eye problem. Your doctor may want eye doctor to check your eyes.

This medicine may affect blood sugar levels. Diabetic patients may notice a change in the results of blood or urine sugar tests. Talk to your doctor if you have any questions.

Do not take other medicines unless they have been discussed with your doctor. This especially includes prescription or nonprescription (over-the-counter [OTC]) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

Bladder pain

bloating or swelling of the face, arms, hands, lower legs, or feet

bloody or cloudy urine

blurred vision

chest pain

difficult, burning, or painful urination

flushed, dry skin

frequent urge to urinate

fruit-like breath odor

increased hunger

increased urination

joint pain, stiffness, or swelling

lower back, side, or stomach pain

rapid weight gain

sweating

swelling of the feet or lower legs

tingling of the hands or feet

troubled breathing

unexplained weight loss

unusual weight gain or loss

Rare

Swelling or puffiness of the face

Incidence not known

Convulsions

decrease in the amount of urine

diarrhea (severe) with weight loss

dizziness, faintness, or lightheadedness when getting up from a lying or sitting position

rash

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Back pain

body aches or pain

chills

cough

difficulty with breathing

ear congestion or pain

fever

headache

head congestion

hoarseness or other voice changes

loss of voice

runny or stuffy nose

sneezing

sore throat

Less common

Acid or sour stomach

belching

difficulty with moving

dizziness or lightheadedness

feeling of constant movement of self or surroundings

heartburn

indigestion

joint pain, stiffness, or swelling

loss of appetite

muscle pain or stiffness

pain, swelling, or redness in the joints

sensation of spinning

stomach discomfort or upset

weakness

Incidence not known

Diarrhea

muscle pain or stiffness

nervousness

weakness or heaviness of the legs

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.